Senior Associate

Description:

Proclinical Staffing is seeking a highly skilled Senior Associate – Technical Services Manufacturing Science (TSMS) to join their team in a hybrid capacity in Speke, UK. This position plays a crucial role in overseeing finished product manufacturing operations within external sites, ensuring compliance, optimizing technical performance, and supporting product launches and transfers.

Key Responsibilities:

• Serve as the primary TSMS contact during Joint Process Team (JPT) meetings to uphold global technical standards.

• Provide specialized knowledge in packaging materials and processes.

• Develop, review, and oversee GMP-compliant documentation, including SOPs, Master Production Records, SPIs, and technical reports.

• Participate in site visits to contract manufacturing organizations to resolve issues and ensure capability alignment.

• Support and manage technical transfer initiatives, new product introductions, and continuous improvement programs.

• Conduct root cause investigations for deviations and complaints in collaboration with internal teams.

• Represent technical content effectively to senior leadership and external partners.

• Develop and maintain robust control strategies for assigned pharmaceutical products.

• Contribute to the preparation of Annual Product Reports (APRs) and Product Quality Reviews (PQRs).

• Travel up to 30% as needed for business-critical operations.

Candidate Requirements:

• Advanced academic qualifications or equivalent in life sciences, pharmacy, chemistry, chemical engineering, or related fields.

• Deep understanding of pharmaceutical production and packaging operations.

• Experience in managing technical documentation and compliance under cGMP standards.

• Skilled in applied statistics, regulatory standards, and data-driven process improvements.

• Proficient in project management and stakeholder communication within interdisciplinary, multicultural teams.

• Strong technical writing and analytical abilities with a problem-solving mindset.

• Multilingual capabilities are a plus, but fluency in English is required.

• Flexibility to travel 10–30% for site support and project delivery.